Monitored vs Standard Supplementation of Vitamin D in Preterm Infants
NCT ID: NCT03087149
Last Updated: 2021-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2017-05-01
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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monitored group
The monitored group will received monitored vit D supplementation
monitored vit D supplementation
The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born \<30 GA, at 8 week of age for infants born \<26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.
standard group
The standard group will receive standard vit D supplementation
standard vit D supplementation
The vitamin D supplementation dose is 500IU from 7th day of age.
Interventions
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monitored vit D supplementation
The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born \<30 GA, at 8 week of age for infants born \<26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.
standard vit D supplementation
The vitamin D supplementation dose is 500IU from 7th day of age.
Eligibility Criteria
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Inclusion Criteria
* In born or admitted to the unit within 48hours from birth.
* Randomization within 7 days from birth.
* Parental consent.
* Mothers willing to return for follow up visits.
Exclusion Criteria
* Major congenital abnormalities.
* Participation in another trial.
* Severe illness at birth deemed incompatible with survival.
* Congenital HIV infection.
* Total parenteral nutrition \> 14 days.
* Cholestasis
1 Day
7 Days
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Princess Anna Mazowiecka Hospital, Warsaw, Poland
OTHER
Responsible Party
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Alicja Kołodziejczyk
PhD student
Principal Investigators
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Maria K Borszewska-Kornacka, Professor
Role: STUDY_CHAIR
Princess Anna Mazowiecka Hospital
Renata Bokiniec, M.D.
Role: STUDY_DIRECTOR
Princess Anna Mazowiecka Hospital
Locations
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Princess Anna Mazowiecka Hospital
Warsaw, , Poland
Countries
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References
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Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Kouri T, Maki M. Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1999 May;80(3):F161-6. doi: 10.1136/fn.80.3.f161.
Rigo J, Pieltain C, Salle B, Senterre J. Enteral calcium, phosphate and vitamin D requirements and bone mineralization in preterm infants. Acta Paediatr. 2007 Jul;96(7):969-74. doi: 10.1111/j.1651-2227.2007.00336.x.
Zerofsky M, Ryder M, Bhatia S, Stephensen CB, King J, Fung EB. Effects of early vitamin D deficiency rickets on bone and dental health, growth and immunity. Matern Child Nutr. 2016 Oct;12(4):898-907. doi: 10.1111/mcn.12187. Epub 2015 Apr 7.
Zhu K, Whitehouse AJ, Hart PH, Kusel M, Mountain J, Lye S, Pennell C, Walsh JP. Maternal vitamin D status during pregnancy and bone mass in offspring at 20 years of age: a prospective cohort study. J Bone Miner Res. 2014;29(5):1088-95. doi: 10.1002/jbmr.2138.
Dinlen N, Zenciroglu A, Beken S, Dursun A, Dilli D, Okumus N. Association of vitamin D deficiency with acute lower respiratory tract infections in newborns. J Matern Fetal Neonatal Med. 2016 Mar;29(6):928-32. doi: 10.3109/14767058.2015.1023710. Epub 2015 Mar 19.
Grant CC, Kaur S, Waymouth E, Mitchell EA, Scragg R, Ekeroma A, Stewart A, Crane J, Trenholme A, Camargo CA Jr. Reduced primary care respiratory infection visits following pregnancy and infancy vitamin D supplementation: a randomised controlled trial. Acta Paediatr. 2015 Apr;104(4):396-404. doi: 10.1111/apa.12819. Epub 2014 Oct 21.
Gernand AD, Simhan HN, Caritis S, Bodnar LM. Maternal vitamin D status and small-for-gestational-age offspring in women at high risk for preeclampsia. Obstet Gynecol. 2014 Jan;123(1):40-48. doi: 10.1097/AOG.0000000000000049.
Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Kusel MM, Hart PH. Maternal serum vitamin D levels during pregnancy and offspring neurocognitive development. Pediatrics. 2012 Mar;129(3):485-93. doi: 10.1542/peds.2011-2644. Epub 2012 Feb 13.
Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, Shoenfeld Y, Lerchbaum E, Llewellyn DJ, Kienreich K, Soni M. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality-a review of recent evidence. Autoimmun Rev. 2013 Aug;12(10):976-89. doi: 10.1016/j.autrev.2013.02.004. Epub 2013 Mar 28.
Vogiatzi MG, Jacobson-Dickman E, DeBoer MD; Drugs, and Therapeutics Committee of The Pediatric Endocrine Society. Vitamin D supplementation and risk of toxicity in pediatrics: a review of current literature. J Clin Endocrinol Metab. 2014 Apr;99(4):1132-41. doi: 10.1210/jc.2013-3655. Epub 2014 Jan 23.
Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.
Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463.
Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Hart PH, Kusel MM. Maternal vitamin D levels and the autism phenotype among offspring. J Autism Dev Disord. 2013 Jul;43(7):1495-504. doi: 10.1007/s10803-012-1676-8.
Cetinkaya M, Cekmez F, Erener-Ercan T, Buyukkale G, Demirhan A, Aydemir G, Aydin FN. Maternal/neonatal vitamin D deficiency: a risk factor for bronchopulmonary dysplasia in preterms? J Perinatol. 2015 Oct;35(10):813-7. doi: 10.1038/jp.2015.88. Epub 2015 Jul 30.
Cizmeci MN, Kanburoglu MK, Akelma AZ, Ayyildiz A, Kutukoglu I, Malli DD, Tatli MM. Cord-blood 25-hydroxyvitamin D levels and risk of early-onset neonatal sepsis: a case-control study from a tertiary care center in Turkey. Eur J Pediatr. 2015 Jun;174(6):809-15. doi: 10.1007/s00431-014-2469-1. Epub 2014 Dec 12.
Abrams SA; Committee on Nutrition. Calcium and vitamin d requirements of enterally fed preterm infants. Pediatrics. 2013 May;131(5):e1676-83. doi: 10.1542/peds.2013-0420. Epub 2013 Apr 29.
Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.
Pludowski P, Karczmarewicz E, Bayer M, Carter G, Chlebna-Sokol D, Czech-Kowalska J, Debski R, Decsi T, Dobrzanska A, Franek E, Gluszko P, Grant WB, Holick MF, Yankovskaya L, Konstantynowicz J, Ksiazyk JB, Ksiezopolska-Orlowska K, Lewinski A, Litwin M, Lohner S, Lorenc RS, Lukaszkiewicz J, Marcinowska-Suchowierska E, Milewicz A, Misiorowski W, Nowicki M, Povoroznyuk V, Rozentryt P, Rudenka E, Shoenfeld Y, Socha P, Solnica B, Szalecki M, Talalaj M, Varbiro S, Zmijewski MA. Practical guidelines for the supplementation of vitamin D and the treatment of deficits in Central Europe - recommended vitamin D intakes in the general population and groups at risk of vitamin D deficiency. Endokrynol Pol. 2013;64(4):319-27. doi: 10.5603/ep.2013.0012.
Monangi N, Slaughter JL, Dawodu A, Smith C, Akinbi HT. Vitamin D status of early preterm infants and the effects of vitamin D intake during hospital stay. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F166-8. doi: 10.1136/archdischild-2013-303999. Epub 2013 Jul 13.
Pinto K, Collins CT, Gibson RA, Andersen CC. Vitamin D in preterm infants: A prospective observational study. J Paediatr Child Health. 2015 Jul;51(7):679-81. doi: 10.1111/jpc.12847. Epub 2015 Feb 12.
Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
Backstrom MC, Kouri T, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Maki M. Bone isoenzyme of serum alkaline phosphatase and serum inorganic phosphate in metabolic bone disease of prematurity. Acta Paediatr. 2000 Jul;89(7):867-73.
Nemet D, Dolfin T, Wolach B, Eliakim A. Quantitative ultrasound measurements of bone speed of sound in premature infants. Eur J Pediatr. 2001 Dec;160(12):736-40. doi: 10.1007/s004310100849.
Rack B, Lochmuller EM, Janni W, Lipowsky G, Engelsberger I, Friese K, Kuster H. Ultrasound for the assessment of bone quality in preterm and term infants. J Perinatol. 2012 Mar;32(3):218-26. doi: 10.1038/jp.2011.82. Epub 2011 Jun 16.
Kolodziejczyk A, Borszewska-Kornacka MK, Seliga-Siwecka J. MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial. Trials. 2017 Sep 11;18(1):424. doi: 10.1186/s13063-017-2141-y.
Related Links
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Other Identifiers
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VitD-2016
Identifier Type: -
Identifier Source: org_study_id
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